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Home / Activities / Classification of borderline products

Classification of borderline products

In order to protect public health on behalf of the Licensing Authority, the Medicines Authority regulates medicinal products for human use in accordance with the European Community Pharmaceutical Directives and Maltese legislation.  Directive 2001/83/EC and the Medicines Act, 2003 (Act No. III of 2003) state that:

A medicinal product means any substance or combination of substances: 

  1. "presented as having properties for treating or preventing disease in human beings; or
  2. "which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis".

Most human medicines are clearly identifiable as such and are subject to EU Marketing Authorisation regulations (i.e. need to have a marketing authorisation to be placed on the market). However, there are some instances where it is not so easy to distinguish medicinal products from, for example, cosmetics, medical devices or food supplements. These are known as 'borderline products' (until classified).  The Borderline Classification Committee classifies borderline products into medicinal or non- medicinal products, in line with definition in the pharmaceutical legislation. Products for which medicinal claims are made or which contain substances likely to have pharmacological or toxicological actions in the body are likely to be considered as medicines, and will therefore need a Marketing Authorisation to be placed on the market.  More information can be found in the Guideline for Borderline Products - 'A Guide to What is a Medicinal Product'.

Please refer to the Application Form for the classification of a borderline product and the Guidelines on how to complete the application form.  The e-form is to be filled in online, downloaded and saved as a .pdf document.  Please send form and annexes to the mailbox classcom.adm@gov.mt.

Please also refer to the Terms of Reference of the Borderline Classification Committee, which explain the composition and remit of the committee together with a description of how determinations are made.

Below please find a list of products classified as Medicinal products by date:

List of products classified as Medicinal Products between May 2004 and June 2006

List of products classified as Medicinal Products between July 2006 and December 2007

List of products classified as Medicinal Products between January 2008 and September 2009

List of products classified as Medicinal Products between October 2009 and January 2011

List of products classified as Medicinal Products between February 2011 and June 2012 

List of products classified as Medicinal Products between 2013 - 2019

List of products classified as Medicinal Products 2020 - 2022

 

NOTICE:

Products containing local anaesthetics, including, but not limited to lidocaine and prilocaine, which primary action and intention is for anaesthesia, are considered to be medicinal products.  Such products are considered to fall within the second part of the definition of a medicinal product in accordance with Directive 2001/83/EC, as transposed into Maltese law, namely the Medicines Act Chapter 458 of the Laws of Malta, due to having a pharmacological, immunological or metabolic action.

Updated on: 15 May 2023